UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045231
Receipt number R000051670
Scientific Title Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Date of disclosure of the study information 2021/09/14
Last modified on 2021/08/23 17:30:36

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Basic information

Public title

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states

Acronym

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states

Scientific Title

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states

Scientific Title:Acronym

Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the effect of Probiotic on mood states among healthy adults

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cerebral blood flow, Saliva Stress Index, Questionnaire

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of powdered probiotic for 6 weeks

Interventions/Control_2

Intake of powdered placebo for 6 weeks

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Subjects of both sexes aged 20 years or older and younger than 65 years.

Key exclusion criteria

1) Subjects with serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, mental and metabolic system, or related severe past medical histories
2) Subjects who are under alternative treatment (acupuncture, chiropractic and etc.) or with treatment histories of within 1 month
3) Subjects with suicide thoughts
4) Subjects who regularly take foods containing Lactic acid bacteria or Bifidobacterium such as supplements
5) Subjects who regularly intake medical drugs or supplements that affect moods or fatigue
6) Subjects with medication allergy, food allergy, or serious history of these
7) Subjects who are pregnant, under lactation or expecting to be pregnant during this study
8) Subjects who participated in other study within 1 month prior to obtaining informed consent
9) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hirotaka
Middle name
Last name Nagashima

Organization

Medical Corporation Chisei-kai Tokyo Center Clinic

Division name

Clinical Research Center

Zip code

103-0028

Address

Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo, Japan

TEL

03-3276-6935

Email

nagashima_hirotaka@tc-clinic.jp


Public contact

Name of contact person

1st name Shigeru
Middle name
Last name Imai

Organization

Leverage Brain Inc.

Division name

Clinical Trial Department

Zip code

105-0004

Address

Shinbashi2-16-1 Minato-ku, Tokyo, Japan

TEL

080-7290-0404

Homepage URL


Email

imai@levbrain.com


Sponsor or person

Institute

Leverage Brain Inc.

Institute

Department

Personal name



Funding Source

Organization

Morinaga Milk Industry Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Conference of Clinical Research

Address

1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan

Tel

03-6868-7022

Email

jccr-info@cts-smo.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

医療法人社団 知正会 東京センタークリニック(東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 14 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2021 Year 07 Month 05 Day

Date of IRB

2021 Year 08 Month 19 Day

Anticipated trial start date

2021 Year 09 Month 15 Day

Last follow-up date

2021 Year 11 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 08 Month 23 Day

Last modified on

2021 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051670


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name